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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nailing System recalled for fracture risk

Zimmer Biomet
OTHERNationwide distribution

Contact your surgeon about Zimmer Affixus nail

Zimmer, Inc. is recalling certain Affixus 9 mm, 300 mm Left Trochanteric Femoral Nails (Model 815609300, Lot 66717600) because the implant shaft may be undersized, which could cause it to crack or break inside the body. If the nail fractures, patients may experience pain, improper bone healing, tissue damage, or need another surgery.

  • If you received this implant, contact your surgeon immediately to discuss whether you are affected
  • Do not stop treatment or remove the implant without medical guidance
  • Ask your surgeon about monitoring or follow-up imaging
Hazard

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Sold states
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Affected count
11
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0974-2026

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